ABL90 FLEX, Clot catcher

Basic Information

• Brand Name: ABL90 FLEX, Clot catcher
• Primary DI: 05700699060266
• Version / Model: 906-026
• Catalog Number: 906-026
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 5
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: c9bd93da-c1bc-47c1-bc08-d226110321f0

Device Description

ABL90 FLEX, Clot catcher, box of 250 pcs.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH	Clinical Chemistry	862.1120	2
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE	Clinical Chemistry	862.1150	2
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED	Hematology	864.5620	2
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM	Clinical Chemistry	862.1113	1
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
GHS	ASSAY, CARBOXYHEMOGLOBIN	Hematology	864.7425	2
KQI	ASSAY, FETAL HEMOGLOBIN	Hematology	864.7455	2
JFP	ELECTRODE, ION SPECIFIC, CALCIUM	Clinical Chemistry	862.1145	2
JJY	Multi-analyte controls, all kinds (assayed)	Clinical Chemistry	862.1660	1
KHP	ACID, LACTIC, ENZYMATIC METHOD	Clinical Chemistry	862.1450	1
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66079	Analyser blood clot protection filter IVD	A screening device intended to be placed in a blood specimen receptacle (e.g., capillary blood collection tube) prior to loading it into an in vitro diagnostic analyser (e.g., blood gas analyser) to trap blood clots and prevent them from entering the analyser. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700699060266	GS1
Unit of Use	55700699060261	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]